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This study will investigate if treatment with vernakalant hydrochloride (MK-6621) results in a greater proportion of patients with treatment-induced conversion of Atrial Fibrillation to sinus rhythm compared to placebo.
Amendment 4 of the protocol revised the planned enrollment to 123 participants and removed China as one of the countries participating in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vernakalant HCl | Experimental | vernakalant hydrochloride |
|
| placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vernakalant hydrochloride | Drug | Patients will receive a 3 mg/kg infusion of vernakalant hydrochloride. If the patient is in atrial fibrillation (AF) or atrial flutter (AFL) 25 minutes after the start of the infusion, then a second infusion of 2 mg/kg vernakalant hydrochloride will be administered. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Treatment-induced Conversion of Atrial Fibrillation to Sinus Rhythm | The proportion of patients with treatment-induced conversion of atrial fibrillation to sinus rhythm for a minimum duration of 1 minute | Within 90 minutes after first exposure |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Vernakalant IV | vernakalant hydrochloride Up to two 10-min infusions of 3mg/kg +/- 2mg/kg vernakalant IV |
| FG001 | Placebo | placebo Up to two 10-min infusions of normal saline |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vernakalant IV | vernakalant hydrochloride Up to two 10-min infusions of 3mg/kg +/- 2mg/kg vernakalant IV |
| BG001 | Placebo | placebo Up to two 10-min infusions of normal saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Patients With Treatment-induced Conversion of Atrial Fibrillation to Sinus Rhythm | The proportion of patients with treatment-induced conversion of atrial fibrillation to sinus rhythm for a minimum duration of 1 minute | Posted | Number | participants | Within 90 minutes after first exposure |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vernakalant IV | vernakalant hydrochloride Up to two 10-min infusions of 3mg/kg +/- 2mg/kg vernakalant IV |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Mather, Director, Head of Regulatory Affairs | Cardiome Pharma | +44 (0)7581148916 | jmather@cardiome.com |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
|
| Placebo to vernakalent hydrochloride | Drug | Patients will receive an infusion of placebo. If the patient is in atrial fibrillation (AF) or atrial flutter (AFL) 25 minutes after the start of the infusion, then a second infusion of placebo will be administered. |
|
|
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| New York Heart Association (NYHA) Classification | NHYA classifies the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina pain. | Number | participants |
|
| Structural Heart Disease | Participants could have been classified in more than one category | Number | participants |
|
| Atrial fibrillation (AF) duration | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 6 |
| 55 |
| 23 |
| 55 |
| EG001 | Placebo | placebo Up to two 10-min infusions of normal saline | 6 | 56 | 23 | 56 |
| Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | Systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment | General disorders and administration site conditions |
|
| Cerebral infarction | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Prothrombin time prolonged | Investigations | Systematic Assessment |
|
| Acute renal failure | Renal and urinary disorders | Systematic Assessment |
|
| Neurogenic shock | Vascular disorders | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | Systematic Assessment |
|
| Sick sinus syndrom | Cardiac disorders | Systematic Assessment |
|
| Hypertensive heart disease | Cardiac disorders | Systematic Assessment |
|
| Palpitations | Cardiac disorders | Systematic Assessment |
|
| Sinus arrest | Cardiac disorders | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | Systematic Assessment |
|
| Chest discomfort | General disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Asthenia | General disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Generalised oedema | General disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | Systematic Assessment |
|
| Intestinal polyp | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Wound complications | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Weight decreased | Investigations | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Anxiety disorder | Psychiatric disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | Systematic Assessment |
|
| Acute renal failure | Renal and urinary disorders | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Bicytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | Systematic Assessment |
|
The PI agrees to submit a copy of a 'Publication' to CRO/Sponsor for review and comment 60 days prior to submission for publication and / or disclosure. Sponsor has the applicable 60 day period to respond to PI with any requested revisions. PI agrees to delete any confidential information (excluding results) identified by Sponsor as confidential prior to submitting/presenting the publication.
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D017670 |
| Sodium Compounds |